Stryker Precision 6425127105Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327143744), received between Jan 29, 2019 and Jul 22, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25907824 ↗
• MalfunctionJan 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 0 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200775 ↗
• MalfunctionJan 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556976 ↗
• MalfunctionJul 26, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397003 ↗
• MalfunctionMar 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THE BROKEN METAL FRAGMENT WAS REMOVED WITH A HEMOSTAT AND THERE WERE NO FRAGMENTS LEFT BEHIND IN THE SURGICAL SITE. IT WAS ALSO REPORTED THAT THERE WAS A FIFTEEN MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13773414 ↗
• MalfunctionNov 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING PREPARATION FOR A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12813860 ↗
• MalfunctionNov 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING PREPARATION FOR A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780292 ↗
• MalfunctionNov 1, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGERY, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728079 ↗
• MalfunctionJun 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PREPARATION FOR A SURGICAL PROCEDURE, A RESIDUE WAS NOTED ON THE BLADE . IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042257 ↗
• MalfunctionJul 13, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE, IT WAS NOTED THAT THE SEAL ON THE PACKAGING OF THE DEVICE WAS OPEN. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10265236 ↗
• MalfunctionMar 23, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A TKA (TOTAL KNEE ARTHROPLASTY) , WHEN A NURSE WAS OPENING THE PACKAGE, SHE NOTICED A PINHOLE ON IT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9866827 ↗
• MalfunctionApr 18, 2019Break; Break

  IT WAS REPORTED THAT DURING PREPARATION FOR A SURGICAL PROCEDURE, IT WAS NOTED THAT THE TIP OF BLADE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. UPDATE; IT WAS SUBSEQUENTLY REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE TIP OF BLADE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529500 ↗
• MalfunctionJan 29, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE BROKE DURING A TKA (TOTAL KNEE ARTHROPLASTY) PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8286858 ↗